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510(k) K152349

Star+ VPS Scannable Impression Material by Danville Materials, LLC — Product Code ELW

K152349 is an FDA 510(k) premarket notification submitted by Danville Materials, LLC for the device "Star+ VPS Scannable Impression Material". The FDA issued a decision of Substantially Equivalent on November 23, 2015. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Danville Materials, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2015
Date Received
August 20, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

Other clearances by Danville Materials, LLC

  • K151514 — Prestige (September 21, 2015)
  • K151088 — DMRC Bulk Fill (August 28, 2015)
  • K142886 — DMRC Self-Cure Bracket Adhesive One Step and Primer (March 18, 2015)
  • K142881 — DMRC Dual Cure Orthodontic Band Cement (February 13, 2015)
  • K121880 — DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID (September 25, 2012)
  • K111876 — Z BOND, PRELUDE ONE (September 21, 2011)
  • K110642 — SILJETR SYSTEM (May 27, 2011)
  • K102753 — TURBO TEMP 3 (February 4, 2011)
  • K092912 — STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW V (December 16, 2009)
  • K092319 — STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 (September 16, 2009)

Other clearances for product code ELW

  • K254112 — Dia-X Sil Bite (March 19, 2026)
  • K253501 — Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular (October 31, 2025)
  • K250969 — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST (June 27, 2025)
  • K241924 — Elastic Impression Material (December 27, 2024)
  • K242360 — Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex U (November 15, 2024)
  • K233954 — Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu (February 13, 2024)
  • K223892 — DentMix VPS Impression Material (April 27, 2023)
  • K213175 — No Stress Impress (January 19, 2023)
  • K214086 — Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impres (December 15, 2022)
  • K222741 — DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(R (November 7, 2022)

FDA data resources